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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION FLEXENT EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC STEALTHSTATION FLEXENT EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9736242
Device Problems Environmental Compatibility Problem (2929); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/03/2021
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 9736217, (computer aio flex ent svc) serial/lot #unknown, udi#: unknown. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation device being used outside of a procedure. It was reported that the system shut down unexpectedly. Reboot resolved. There was no patient present.
 
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Brand NameSTEALTHSTATION FLEXENT
Type of DeviceEAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key12537195
MDR Text Key273534596
Report Number1723170-2021-02381
Device Sequence Number1
Product Code PGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K200723
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 10/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9736242
Device Catalogue Number9736242
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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